Repeated Transforaminal Anesthetic Injections With or Without Glucocorticoid in Patients With Cervical Radiculopathy

NCT03541681 | Withdrawn

• 1 other identifier: Dnr 2017/804
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective is to evaluate pain and muscle strength in the upper extremities after treatment with cervical transforaminal injection of glucocorticoid vs. transforaminal injection of local anesthetic injection in patients with cervical radiculopathy. The investigators hypothesizes that there are correlations between radiculopathy and muscle weakness.

Conditions

Neck Pain; Radiculopathy, Cervical; Cervical Foraminal Stenosis; Cervical Disc Disease

Keywords

Epidural Steroid Injections; Cervical Epidural Injections; Transforaminal Epidural Injections; Steroids; Local Anesthetic

Outcome Measures

Primary Outcomes (1)

• VAS - Visual analog scale

  VAS evaluates levels of pain intensity using an 10 point scale (range 0-10), with 0 being classified as "no pain", and 10 "worst imaginable pain".

  6 months

Secondary Outcomes (6)

• Muscle strength - ISOmetric Power device

  6 months

• Muscle strength - Commander Echo (JTECH Medical)

  6 months

• Neck disability index

  6 months

• EQ-5D-3L

  6 months

• Odom´s criteria

  6 months

Other Outcomes (1)

• The Swedish National Spine Register

  6 months

Study Arms (2)

Glucocorticoid Injections

ACTIVE COMPARATOR

A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections with glucocorticoid (1 ml Dexamethasone) within 3 months.

Procedure: Glucocorticoid Injections; Procedure: Anesthetic Injections

Local Anesthetic Injections

ACTIVE COMPARATOR

A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections without glucocorticoid (Dexamethasone) within 3 months.

Procedure: Anesthetic Injections

Interventions

Glucocorticoid Injections PROCEDURE

1 ml Dexamethasone + 0,5 ml Bupivacain

Glucocorticoid Injections

Anesthetic Injections PROCEDURE

0,5 ml Bupivacain

Glucocorticoid Injections; Local Anesthetic Injections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People \>18 years and \<65, referred to the department of Neurosurgery in Lund, Sweden for evaluation and treatment of cervical radiculopathy.
• Patients with radiculopathy who after a diagnostic transforaminal injection with 0,5 ml Bupivacain local anesthetics reported a 50% or more reduction of radicular pain according to the visual analogue scale (VAS) (responders).
• Clinical findings and symptoms (i.e. radiculopathy, muscle weakness, sensibility disorder, reflexes) in the upper extremities, correlating to MRI verified nerve root compression on one single level between C4-C7 caused by spondylosis or disc herniation.
• Patients with positive, \>50% pain reduction, diagnostic transforaminal injection who choose conservative treatment as first option before surgery.
• Symptoms from dermatome/myotome radiculopathy \> 3 months, corresponding to MR-verified foraminal narrowing caused by disc herniation or foraminal stenosis from spondylosis/facet joint hypertrophy.
• Understanding the oral and written consent form in Swedish, and consenting to the study.
• Capable of adhering to the protocol.

You may not qualify if:

• Fibromyalgia or other general myalgia not suggestive of radicular pain.
• Cervical myelopathy caused by central spinal stenosis.
• Pain caused by stenosis 3 levels or more and/or disk herniation at 3 levels or more or cervical abnormalities (Klippel-Feil, Lytic/Sclerotic lesions, Recent fractures).
• Previously cervical surgery at the same level or trauma caused by neck distortion i.e. whiplash-associated disorder (WAD).
• Peripheral neuropathy caused by systemic disorders (i.e. diabetes, hereditary, idiopathic or ethanol overconsumption).
• Peripheral nerve compression/entrapment distal to the neuro foramina (i.e. Thoracic outlet syndrome, compression between mm. scalenus, carpal tunnel syndrome)
• Systematic inflammatory diseases involving cervical spine segments and/or spinal cord.
• Neurological motor disorders e.g. ALS and MS.
• Prior medical conditions causing difficulties to participate according to the protocol i.e. stroke, dementia and mental illness.
• Treatment with glucocorticoids injections in the cervical spine within the last 12 months.
• Allergy to glucocorticoid (Dexamethasone) or local anesthetic (Bupivacain).

Sponsors & Collaborators

• Region Skane: lead

Related Publications (1)

• Brandt C, Eskilsson A, Tomasevic G. Marklund N. Repeated transforaminal injections in patients with cervical radiculopathy: A randomized trial comparing local anesthetic and glucocorticoid injections on pain and muscle strength. ClinicalTrials.gov [Internet] Identifier Dnr 2017/804, 2018.

  RESULT

MeSH Terms

Conditions

Neck Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Niklas Marklund, Professor

  Region Skane

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 30, 2018
• Study Start: June 1, 2021
• Primary Completion: June 7, 2023
• Study Completion: December 30, 2023
• Last Updated: June 25, 2025

Record last verified: 2020-03